Recall archive
353 recalls · page 13 of 15
Reported Mar 26, 2014
GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your…
FDA (openFDA device enforcement)
Reported Mar 19, 2014
GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova 3131IQ;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2014
GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On-…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature.…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 5, 2014
GE Healthcare - Giraffe Warmer;Panda Warmer;Panda iRes Warmer, Giraffe Stand-alone Infant Resuscitation System. Product…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details — Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2014
GE Healthcare, PET Discovery 610, Discovery 710, Discovery 600 and Discovery 690. The GE Discovery XR and XA Systems…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to scatter overcorrection associated with the List Mode Replay feature of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2014
GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue involving the Precision 500D, Precision MPI & Precision RXI X-ray imaging systems…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 12, 2014
Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare
Matched: Brand · Product · Product details — Medical device adjustment knob may be loose and affect the accuracy of blended Air/Oxygen gas mixture to patients.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2014
The Centricity Laboratory System is intended to be an information system designed to support the clinical and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.GE Healthcare It
Matched: Brand · Reason for recall — GE Healthcare is aware of a potential safety issue associated with the use of GE Centricity Laboratory Core Lab calculated results in two scenarios.…
FDA (openFDA device enforcement)
Reported Feb 5, 2014
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 29, 2014
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — Missing screws in the overhead Video Monitor Suspension. GE discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2014
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centricity PACS Workstation is…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Healthcare It
Matched: Brand · Product details — There is a potential loss of image(s) associated with the Centricity to Centricity (C2C) exam transfer module of Centricity PACS System versions 3.X…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2014
GE Optima XR220amx and Optima XR200amx with Digital Upgrade Mobile Radiographic Systems. Model numbers 5555000-5,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details — There exists a software issue associated with patient selection from the worklist on the Optima XR200 with Digital Upgrade, and Optima XR220amx…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 15, 2014
SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue which affects all Patient Date Modules produced from April 2007 through June…
FDA (openFDA device enforcement)
Reported Jan 8, 2014
The Centricity Laboratory System is intended to be an information system designed to support the clinical and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare It
Matched: Brand · Reason for recall — GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is…
FDA (openFDA device enforcement)
Reported Dec 25, 2013
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare…
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
FDA (openFDA device enforcement)
Reported Dec 18, 2013
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient…
FDA (openFDA device enforcement)
Reported Dec 11, 2013
The GE Centricity Web; Software Version 3.0x, is intended for use under the direct supervision of a licensed healthcare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ge Healthcare It
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has become aware of an issue associated with rejected images using the WADO protocol within GE Centricity Web that may impact patient…
FDA (openFDA device enforcement)
Reported Nov 27, 2013
The Centricity Laboratory System is intended to be an information system designed to support the clinical and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare It
Matched: Brand · Reason for recall — GE Healthcare has become aware of a potential safety issue associated with the use of GE Centricity Laboratory where panel reflex does not occur if…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2013
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2013
AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION), AW Server.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare, LLC
Matched: Brand · Reason for recall — GE Healthcare has recently become aware of a potential safety issue due to the image orientation within GSI viewer on AW products. The GSI Viewer…
FDA (openFDA device enforcement)
Reported Nov 6, 2013
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare It
Matched: Brand · Product details · Reason for recall — GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 30, 2013
GE Brivo OEC715/785/865 C-Arm, Models: 715 Prime, 785 Essential, and 865 Plus. The QEC Brivo Mobile C-Arm X-Ray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare Beijing , Hangwei Medical Systems, Co. Ltd.
Matched: Brand · Product · Product details · Reason for recall — GE is recalling certain lots of GE Brivo OEC715/785/865 C-Arm due to the potential for the wires in the high voltage cable bundle to fail, resulting…
FDA (openFDA device enforcement)
Reported Oct 30, 2013
Centricity Cardio Imaging 5.0 is a software only Picture Archiving and Communication System (PACS). Product Usage: It…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.GE Healthcare It
Matched: Brand · Reason for recall — GE Healthcare is aware of a potential safety risk where an image labeling situation exists in the Image Viewer software of the Centricity Cardio…
FDA (openFDA device enforcement)
Reported Oct 23, 2013
GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation.
High riskUsing this product could cause serious injury, illness or death — stop using it now.GE Healthcare, LLC
Matched: Brand · Product · Product details · Reason for recall — GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating…
5 more products in this recall
FDA (openFDA device enforcement)
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